CurrentUnitedHealthcarePolicy CSO18SS.U

Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials

Defines coverage and exclusions for routine patient costs associated with qualifying clinical trials for UnitedHealthcare Medicaid members; applies to most states with state-specific exceptions listed.

Policy Summary

PayerUnitedHealthcare

PolicyMandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials

Policy CodePolicy CSO18SS.U

Change TypeMedical records documentation language addedFDA section updated

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit a provider and principal investigator attestation using the streamlined uniform form and include requested medical records to support coverage determination.

SourceLink

POLICY UPDATE CHANGES

Medical Records Documentation Used for Reviews: Added language that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess eligibility but do not guarantee coverage.

Supporting Information Updated FDA section to reflect the most current information.

physician, lab, imagingexamples of routine patient costs covered

investigational item; data-only servicesmajor exclusions

11states listed

Q0, Q1

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Coverage Criteria for Routine Patient Costs

Qualified Clinical Trial and Coverage Attestation

Covered when ALL of the following are met:

Trial Sponsor/Approval: The study is approved, conducted, or supported by one or more of the following: CDC; NIH (including NCI); AHRQ; CMS; a Department of Veterans Affairs; or the Department of Defense or Department of Energy if reviewed and approved through an HHS-equivalent peer review system

See Criteria for Qualified Clinical Trials list

Regulatory Status: The study is conducted under an investigational new drug (IND) exemption under section 505(i) of the FD&C Act, or an exemption for a biological product under section 351(a)(3) of the PHS Act, or is a drug trial exempt from those exemptions

Phase and Purpose: The trial is a Phase II, Phase III, or Phase IV trial and is conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition

Provider Attestation: Coverage determinations are based on an attestation by the health care provider and principal investigator using a streamlined uniform form (which may reference publicly available trial information such as ClinicalTrials.gov)

See Additional Requirements

Covered Routine Patient Costs

Covered routine patient costs include:

Examples of Covered Services: Physician services; laboratory services; medical imaging services; any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participation to the extent such items or services would be covered outside the trial; items or services required solely for provision or administration of the investigational item when those items or services would otherwise be covered

The policy excludes coverage for the investigational item or service that is the subject of the qualifying clinical trial when that item or service would not otherwise be covered outside the trial. Additionally, routine patient costs do not include items or services provided solely to satisfy data collection or analysis needs that are not used in direct clinical management, including sponsor‑provided items or services furnished free of charge to trial participants.

Laboratory tests and imaging studies performed at a frequency set by the study protocol that are not consistent with signs and symptoms or other standards of care for the diagnosis or treatment are not considered routine patient costs and are excluded from coverage. Providers and reviewers should refer to applicable federal, state, and contractual requirements when assessing whether protocol‑dictated testing frequency meets routine care standards.

Applicable Codes and Modifiers

Applicable Codes and Modifiersmixed

G0276	Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial.
G0293	Noncovered surgical procedure(s) using conscious sedation, regional, general; or spinal anesthesia in a Medicare qualifying clinical trial, per day.
G0294	Noncovered procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day.
G2000	Blinded administration of convulsive therapy procedure, either electroconvulsive therapy (ECT) or magnetic seizure therapy (MST), performed in an approved IDE-based clinical trial, per treatment session.
S9988	Services provided as part of a Phase I clinical trial.
S9990	Services provided as part of a Phase II clinical trial.
S9991	Services provided as part of a Phase III clinical trial.
S9992	Transportation costs to and from trial location and local transportation costs for clinical trial participant and one caregiver/companion.
S9994	Lodging costs for clinical trial participant and one caregiver/companion.
S9996	Meals for clinical trial participant and one caregiver/companion.

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Provider Actions, Billing and Documentation

Documentation Required

Provider Attestation Required

Providers must submit an attestation regarding the appropriateness of the qualifying clinical trial. The attestation should be completed by the treating health care provider and principal investigator, using a streamlined, uniform form (as developed for use by the Secretary) and may reference publicly available trial information (for example, ClinicalTrials.gov). Coverage determinations will be based on this attestation in accordance with applicable federal, state, and contractual requirements.

Attestation must confirm the trial is a qualifying clinical trial and that routine patient costs pertain to the member’s participation.
Attestation may reference public trial identifiers or URLs (eg, ClinicalTrials.gov) as supporting information.

Denial Risk

Medical Records and Supporting Documentation

Include complete medical records and documentation to support that routine patient costs are appropriate for the member and consistent with federal, state, and contractual requirements. Medical records may be required to assess whether the member meets clinical criteria for coverage but do not guarantee coverage. Failure to provide required documentation may result in denial or an inability to determine coverage.

Background

Clinical trials evaluate interventions across sequential phases to determine safety and efficacy. Phase designations range from early safety and dosing studies through larger efficacy and post‑marketing evaluations; the policy notes that routine patient costs include services to prevent, diagnose, monitor, or treat complications arising from participation in these trials, while the investigational item itself is excluded when it would not be covered outside the trial.

Definitions

Qualified Clinical Trial — definition and qualifying agencies/entities (CDC, NIH/NCI, AHRQ, etc.)

DefinitionA Qualified Clinical Trial is a Phase II, Phase III, or Phase IV trial (or otherwise defined trial per policy) that meets the criteria for Qualified Clinical Trials and is conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition.

Qualifying Agencies / EntitiesStudy is approved, conducted, or supported (including in‑kind contributions) by one or more of: Centers for Disease Control and Prevention (CDC); National Institutes of Health (NIH) (includes NCI); Agency for Healthcare Research and Quality (AHRQ); Centers for Medicare and Medicaid Services (CMS); Department of Veterans Affairs (VA).

Other Federal Departments (peer‑review requirement)Studies conducted by the Department of Defense (DoD) or Department of Energy (DoE) are qualifying only if reviewed and approved through a peer‑review system the HHS Secretary determines meets NIH‑equivalent standards (unbiased review by qualified individuals).

Regulatory Status RequirementThe study is conducted under an investigational new drug (IND) exemption under section 505(i) of the FD&C Act; or under a biologics exemption under section 351(a)(3) of the Public Health Service Act; or is a drug trial exempt from those IND/biologics exemption requirements.